Efficacy and Safety Study of Etodolac and Propranolol in Patients With Clinically Progressive Prostate Cancer

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Participants will receive oral doses of 66 mg propranolol and 680 mg etodolac daily. Propranolol will be administered 44 mg with breakfast and 22 mg in the mid-afternoon (3PM). Etodolac will be administered 340 mg with breakfast and 340 mg with dinner.

Drug: VT-122

The following will be used in the study for VT-122: propranolol 22 mg immediate-release capsules and etodolac 340 mg capsules.

Other Names:

propranolol

etodolac

Placebo Comparator: Placebo with physician's choice therapy

Participants will receive physician's choice therapy as the standard of care as well as the placebo capsules that are of the same weight as propranolol and etodolac.

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Ages Eligible for Study:

18 Years and older (Adult, Older Adult)

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Have a confirmed diagnosis of prostate cancer

Male participants who are ≥18 years of age

In the opinion of the investigator, the participants have a life expectancy of at least 3 months.

Two consecutively rising PSA values or two out of three rising PSA values (2.0 ng/mL is the minimum ending value for PSA) at a minimum of 1-week intervals

Able to provide written informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time, for any reason without prejudice

Exclusion Criteria:

The patient has a history of another primary cancer, with the exception of:

Curatively resected non-melanomatous skin cancer;

Other primary solid tumor with no known active disease presents that in the opinion of the investigator that will not affect patient outcome in the setting of current prostate cancer diagnosis.

Contraindication to propranolol, etodolac

Patients on beta blockers

Patients receiving chemotherapy (e.g., docetaxel, cabazitaxel, taxane, or platinum as single agents or in combination) as their cancer treatment

Substance abuse, medical, psychological or social conditions that may, in the opinion of the investigator, interfere with the patient's participation in the study or evaluation of the study results

Known or suspected allergy to the investigational agents or any agent given in association with this trial (hypersensitivity reaction, hives, rash, difficulty breathing swelling of your face, lips, tongue, or throat)

Any condition that is unstable or which in the opinion of the Investigator could jeopardize the safety of the patient and his/her compliance in the study

Patients with uncontrolled diabetes or insulin resistance

Participation in any other investigational trial in which receipt of investigational drug or device occurred within 30 days prior to screening for this study